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CIRCumcision and Urinary Tract Infections in Boys With Posterior Urethral Valves (CIRCUP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01537601
Recruitment Status : Active, not recruiting
First Posted : February 23, 2012
Last Update Posted : February 7, 2018
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de la Réunion

Brief Summary:
Children with posterior urethral valves (PUV) are at risk of presenting febrile urinary tract infections (UTI). Circumcision has been shown to decrease the number of febrile UTIs in healthy children. The effect of circumcision on the number of UTIs in boys with PUV has not yet been studied. Through a prospective randomised trial of children with posterior urethral valves the investigators wish to determine the effect of circumcision on the risk of presenting febrile UTIs. One group will be on antibiotic prophylaxis alone and the other will be on antibiotic prophylaxis plus circumcision performed at the time of valve resection. Both groups will be followed for two years, with clinical examination at 1, 3, 6, 12, 18 and 24 months. A DMSA scan will be performed at 1-2 and 24 months and biological renal function will also be monitored. The relative risk of presenting a febrile UTI in each group will be determined. Clinical, radiological and antenatal data concerning each child will be analysed. At 24 months follow-up, an "impact on family scale" survey (IOFS) will be proposed parents.

Condition or disease Intervention/treatment Phase
Posterior Urethral Valves Procedure: Circumcision Other: Antibiotic prophylaxis alone Not Applicable

Detailed Description:

After diagnosis of posterior urethral valves, children will be randomised either to antibioprophylaxis alone or antibioprophylaxis plus circumcision. Circumcision will be performed at the time of valve resection. Children will undergo a cystogram between 1 and 4 months to control valve resection. They will be followed for two years and the number of febrile UTIs in each group will be compared. The diagnosis of febrile UTI will be confirmed by urethral catheterisation or suprapubic aspiration. A DMSA scan will be performed at the beginning and end of the study to determine whether children who have presented febrile UTIs show deterioration of their DMSA as compared to those who did not present febrile UTIs.

At 24 months follow-up, "impact on family scale" survey (IOFS) whose main objective is to evaluate the impact of family support for a child with posterior urethral valves will be proposed parents.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 92 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Circumcision on the Risk of Febrile Urinary Tract Infections in Children With Posterior Urethral Valves.
Actual Study Start Date : August 2012
Estimated Primary Completion Date : August 2019
Estimated Study Completion Date : August 2019

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Antibiotic prophylaxis alone
Children will be on antibioprophylaxis and will not have a circumcision.
Other: Antibiotic prophylaxis alone
Antibiotic prophylaxis alone

Experimental: Circumcision and antibiotic prophylaxis
Children will have a circumcision at the time of valve resection and will be on antibioprophylaxis
Procedure: Circumcision

Primary Outcome Measures :
  1. Relative risk of presenting a febrile UTI [ Time Frame: 24 months ]

Secondary Outcome Measures :
  1. Number of children with febrile UTIs in each group at two years [ Time Frame: 24 months ]
  2. Evolution of compliance to antibioprophylaxis. [ Time Frame: 24 months ]
  3. Evolution of the grade of reflux [ Time Frame: At diagnosis and at 3 months ]
  4. Comparison of the number of children who will show deterioration of their DMSA scan between children who have had UTIs and those who have not. [ Time Frame: 24 months ]
  5. number and type of adverse effects related to circumcision and antibiotic prophylaxis [ Time Frame: 24 months ]
  6. Identification of the responsible bacteria [ Time Frame: 24 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 28 Days   (Child)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • male
  • aged 0 to 28 days
  • diagnosed with posterior urethral valves within the 28 first day of life
  • holders of parental authority affiliated to French national health insurance
  • informed consent signed by holders of parental authority

Exclusion Criteria:

  • boys with hypospadias or epispadias or any other anomaly rendering circumcision impossible
  • concomitant participation to another clinical trial

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01537601

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Department of pediatric surgery, Bordeaux hospital
Bordeaux, France, 33076
Sponsors and Collaborators
Centre Hospitalier Universitaire de la Réunion
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Principal Investigator: Frédérique Sauvat, MD Regional Hospital Reunion Island - Felix Guyon Site
Principal Investigator: Eric Dobremez, MD CHU Bordeaux, Hôpital Pellegrin Enfants
Principal Investigator: Laurent Fourcade, MD CHU Limoges - Hôpital de la mère et de l'enfant
Principal Investigator: Nicolas Kalfa, MD CHU Montpellier - Hôpital Lapeyronie
Principal Investigator: Frédéric Auber, MD CHU St Jacques - Besançon
Principal Investigator: Benjamin Frémond CHU Rennes
Principal Investigator: Alaa El Ghoneimi, MD CHU Robert Debré
Principal Investigator: Thomas Blanc, MD CHU de Necker Enfants Malades
Principal Investigator: Jean Michel Guys, MD Hôpital d'enfants de la Timone, Marseille
Principal Investigator: Thierry Merrot, MD CHU Nord, Marseille
Principal Investigator: Marc David Leclair, MD CHU Nantes
Principal Investigator: Georges Audry, MD CHU Armand Trousseau, Paris
Principal Investigator: Marie-Laurence Poli-merol, MD CHU de Reims

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Responsible Party: Centre Hospitalier Universitaire de la Réunion Identifier: NCT01537601     History of Changes
Other Study ID Numbers: 2012/CHR/01
First Posted: February 23, 2012    Key Record Dates
Last Update Posted: February 7, 2018
Last Verified: February 2018

Keywords provided by Centre Hospitalier Universitaire de la Réunion:
Posterior urethral valves
Febrile urinary tract infection
Impact on family

Additional relevant MeSH terms:
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Urinary Tract Infections
Urologic Diseases
Anti-Bacterial Agents
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents